Advances in Urology / 2018 / Article / Tab 3

Review Article

Retroperitoneal Lymph Node Dissection as Primary Treatment for Metastatic Seminoma

Table 3

Prospective clinical trials of RPLND in seminoma.

SEMS (Surgery in Early Metastatic Seminoma)PRIMETEST (Trial to Evaluate Progression Free Survival with Primary Retroperitoneal Lymph-Node Dissection (pRPLND) Only in Patients with Seminomatous Testicular Germ Cell Tumors with Clinical Stage IIA/B)

PhaseIIII
Inclusion criteriaTesticular seminoma
Retroperitoneal lymph node 1–3 cm in size
No more than two enlarged lymph nodes
Testicular seminoma
Inguinal, paraaortic, or retroperitoneal lymph nodes classified as local or regional unilateral metastasis
Maximum dimensions of lymph node metastasis 5 cm
Allow patients who have received single dose carboplatin for stage I seminoma
Exclusion criteriaSecond primary malignancy
History of radiation/chemotherapy
Prior scrotal or retroperitoneal surgery
History of radiation/chemotherapy (other than carboplatin)
Serum tumor markersBeta-HCG normal
Allow LDH and AFP up to 1.5 times upper limit of normal
Exclude AFP elevation suspicious for NSGCT
Primary endpoint2-year recurrence-free survival3-year progression-free survival
Secondary endpoints5-year recurrence-free survival
Treatment-free survival (time free from radiotherapy or chemotherapy)
Complication rate (long and short term)
Overall survival
Quality of life
Complication rate
Long-term sequelae
Accrual goal4630
Start dateAugust 2015June 2016
Target completion dateAugust 2020June 2021
Number of institutions91
Primary locationUniversity of Southern CaliforniaDepartment of Urology, Heinrich-Heine University, Duesseldorf
Principal investigatorSiamak DaneshmandPeter Albers